Utilizing Response- and Biology-Based Risk Factors to Guide Therapy in Patients With Non-High-Risk Neuroblastoma

Who is this study for? Patients with Neuroblastoma
Status: Recruiting
Location: See all (222) locations...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

This phase III trial studies how well response and biology-based risk factor-guided therapy works in treating younger patients with non-high risk neuroblastoma. Sometimes a tumor may not need treatment until it progresses. In this case, observation may be sufficient. Measuring biomarkers in tumor cells may help plan when effective treatment is necessary and what the best treatment is. Response and biology-based risk factor-guided therapy may be effective in treating patients with non-high risk neuroblastoma and may help to avoid some of the risks and side effects related to standard treatment.

Eligibility
Participation Requirements
Sex: All
Maximum Age: 1
Healthy Volunteers: No
View:

• Patients must be:

• < 12 months (< 365 days) of age at diagnosis with INRG stage L1; or

• < 18 months (< 547 days) of age at diagnosis with INRG stage L2 or stage Ms neuroblastoma/ganglioneuroblastoma

• Enrollment on ANBL00B1 or APEC14B1 is required for all newly diagnosed patients

• Patients must have newly diagnosed v-myc avian myelocytomatosis viral oncogene neuroblastoma derived homolog (MYCN) non-amplified neuroblastoma (International Classification of Diseases for Oncology [ICD-O] morphology 9500/3) or MYCN non-amplified ganglioneuroblastoma verified by histology

• Patients must meet the specified criteria for one of the treatment groups defined below; genomic features include MYCN gene amplification, segmental chromosome aberrations (somatic copy number loss at 1p, 3p, 4p, or 11q or somatic copy number gain at 1q, 2p, or 17q) and deoxyribonucleic acid (DNA) index

• Favorable genomic features are defined by one or more whole-chromosome gains or hyperdiploid tumor (DNA index > 1) in the absence of segmental chromosome aberrations as defined above

• Unfavorable genomic features are defined by the presence of any segmental chromosome aberration (somatic copy number loss at 1p, 3p, 4p, or 11q or somatic copy number gain at 1q, 2p, or 17q) or diploid tumor (DNA index = 1); this includes copy neutral loss of heterozygosity (LOH)

• Only patients with MYCN non-amplified tumors are eligible for this study

• Group A: patients < 12 months (< 365 days) of age with newly diagnosed INRG stage L1 neuroblastoma/ganglioneuroblastoma who meet the following criteria:

• Greatest tumor diameter < 5 cm of adrenal or non-adrenal origin

• Patients with non-adrenal primaries are eligible, but must have positive uptake on metaiodobenzylguanidine (MIBG) scan or elevated catecholamine metabolites (urine or serum) to support the diagnosis of neuroblastoma

• No prior tumor resection or biopsy

• Group A will be further split into two subsets, which are mutually exclusive, for statistical purposes

• Group A1:

• > 6 months and < 12 months of age with an adrenal primary tumor < 5 cm in greatest diameter OR

• Patients less than 6 months of age with an adrenal primary tumor > 3.1 and < 5 cm in greatest diameter OR

• < 12 months of age with a non-adrenal primary site < 5 cm in greatest diameter

• Group A2: =< 6 months of age with an adrenal primary site and tumor =< 3.1 cm in greatest diameter.

• Group B: patients < 18 months (< 547 days) of age with newly diagnosed INRG stage L2 neuroblastoma/ganglioneuroblastoma who meet the following criteria:

• No life threatening symptoms or no impending neurologic or other organ function compromise (e.g. epidural or intraspinal tumors with existing or impending neurologic impairment, periorbital or calvarial-based lesions with existing or impending cranial nerve impairment, anatomic or mechanical compromise of critical organ function by tumor [abdominal compartment syndrome, urinary obstruction, etc.]); horner syndrome is not considered neurologic compromise

• No prior tumor resection, tumor biopsy ONLY

• Only patients with both favorable histology and favorable genomic features will remain on study as part of Group B; the institution will be notified of histologic and genomic results within 3 weeks of specimen submission on ANBL00B1 or APEC14B1

• Group C: patients < 18 months (< 547 days) of age with newly diagnosed INRG stage Ms neuroblastoma/ganglioneuroblastoma

• No prior radiotherapy or chemotherapy, with the exception of dexamethasone, which is allowed

• All patients and/or their parents or legal guardians must sign a written informed consent

• All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met

Locations
United States
Alaska
Providence Alaska Medical Center
Recruiting
Anchorage
Alabama
Children's Hospital of Alabama
Recruiting
Birmingham
USA Health Strada Patient Care Center
Recruiting
Mobile
Arkansas
Arkansas Children's Hospital
Recruiting
Little Rock
Arizona
Banner Children's at Desert
Recruiting
Mesa
Phoenix Childrens Hospital
Recruiting
Phoenix
Banner University Medical Center - Tucson
Recruiting
Tucson
California
Kaiser Permanente Downey Medical Center
Recruiting
Downey
City of Hope Comprehensive Cancer Center
Active, not recruiting
Duarte
Loma Linda University Medical Center
Recruiting
Loma Linda
Miller Children's and Women's Hospital Long Beach
Recruiting
Long Beach
Cedars Sinai Medical Center
Recruiting
Los Angeles
Children's Hospital Los Angeles
Recruiting
Los Angeles
Valley Children's Hospital
Recruiting
Madera
Kaiser Permanente-Oakland
Recruiting
Oakland
UCSF Benioff Children's Hospital Oakland
Recruiting
Oakland
Children's Hospital of Orange County
Recruiting
Orange
Lucile Packard Children's Hospital Stanford University
Recruiting
Palo Alto
Sutter Medical Center Sacramento
Active, not recruiting
Sacramento
University of California Davis Comprehensive Cancer Center
Recruiting
Sacramento
Naval Medical Center -San Diego
Recruiting
San Diego
Rady Children's Hospital - San Diego
Recruiting
San Diego
UCSF Medical Center-Mission Bay
Recruiting
San Francisco
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Active, not recruiting
Torrance
Colorado
Children's Hospital Colorado
Recruiting
Aurora
Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center
Recruiting
Denver
Connecticut
Connecticut Children's Medical Center
Recruiting
Hartford
Yale University
Recruiting
New Haven
Washington, D.c.
Children's National Medical Center
Recruiting
Washington
MedStar Georgetown University Hospital
Recruiting
Washington
Delaware
Alfred I duPont Hospital for Children
Recruiting
Wilmington
Florida
Broward Health Medical Center
Recruiting
Fort Lauderdale
Golisano Children's Hospital of Southwest Florida
Recruiting
Fort Myers
University of Florida Health Science Center - Gainesville
Active, not recruiting
Gainesville
Memorial Regional Hospital/Joe DiMaggio Children's Hospital
Recruiting
Hollywood
Nemours Children's Clinic-Jacksonville
Recruiting
Jacksonville
Miami Cancer Institute
Recruiting
Miami
Nicklaus Children's Hospital
Recruiting
Miami
University of Miami Miller School of Medicine-Sylvester Cancer Center
Recruiting
Miami
AdventHealth Orlando
Recruiting
Orlando
Arnold Palmer Hospital for Children
Recruiting
Orlando
Nemours Children's Hospital
Recruiting
Orlando
Nemours Children's Clinic - Pensacola
Active, not recruiting
Pensacola
Sacred Heart Hospital
Recruiting
Pensacola
Johns Hopkins All Children's Hospital
Recruiting
Saint Petersburg
Saint Joseph's Hospital/Children's Hospital-Tampa
Recruiting
Tampa
Tampa General Hospital
Recruiting
Tampa
Saint Mary's Hospital
Recruiting
West Palm Beach
Georgia
Children's Healthcare of Atlanta - Egleston
Recruiting
Atlanta
Augusta University Medical Center
Recruiting
Augusta
Memorial Health University Medical Center
Recruiting
Savannah
Hawaii
Kapiolani Medical Center for Women and Children
Recruiting
Honolulu
Tripler Army Medical Center
Recruiting
Honolulu
Iowa
Blank Children's Hospital
Recruiting
Des Moines
University of Iowa/Holden Comprehensive Cancer Center
Recruiting
Iowa City
Idaho
Saint Luke's Cancer Institute - Boise
Recruiting
Boise
Illinois
Lurie Children's Hospital-Chicago
Recruiting
Chicago
University of Chicago Comprehensive Cancer Center
Recruiting
Chicago
University of Illinois
Recruiting
Chicago
Loyola University Medical Center
Recruiting
Maywood
Advocate Children's Hospital-Oak Lawn
Recruiting
Oak Lawn
Advocate Children's Hospital-Park Ridge
Recruiting
Park Ridge
Saint Jude Midwest Affiliate
Recruiting
Peoria
Southern Illinois University School of Medicine
Recruiting
Springfield
Indiana
IU Health North Hospital
Recruiting
Carmel
Ascension Saint Vincent Indianapolis Hospital
Recruiting
Indianapolis
Riley Hospital for Children
Recruiting
Indianapolis
Kentucky
University of Kentucky/Markey Cancer Center
Recruiting
Lexington
Norton Children's Hospital
Recruiting
Louisville
Louisiana
Children's Hospital New Orleans
Recruiting
New Orleans
Ochsner Medical Center Jefferson
Recruiting
New Orleans
Massachusetts
Dana-Farber Cancer Institute
Recruiting
Boston
Massachusetts General Hospital Cancer Center
Recruiting
Boston
Tufts Children's Hospital
Active, not recruiting
Boston
Baystate Medical Center
Active, not recruiting
Springfield
UMass Memorial Medical Center - University Campus
Recruiting
Worcester
Maryland
Johns Hopkins University/Sidney Kimmel Cancer Center
Recruiting
Baltimore
Sinai Hospital of Baltimore
Recruiting
Baltimore
Walter Reed National Military Medical Center
Recruiting
Bethesda
Maine
Eastern Maine Medical Center
Recruiting
Bangor
Maine Children's Cancer Program
Recruiting
Scarborough
Michigan
C S Mott Children's Hospital
Recruiting
Ann Arbor
Ascension Saint John Hospital
Recruiting
Detroit
Children's Hospital of Michigan
Recruiting
Detroit
Wayne State University/Karmanos Cancer Institute
Recruiting
Detroit
Michigan State University Clinical Center
Recruiting
East Lansing
Hurley Medical Center
Active, not recruiting
Flint
Helen DeVos Children's Hospital at Spectrum Health
Recruiting
Grand Rapids
Spectrum Health at Butterworth Campus
Suspended
Grand Rapids
Bronson Methodist Hospital
Recruiting
Kalamazoo
West Michigan Cancer Center
Suspended
Kalamazoo
Beaumont Children's Hospital-Royal Oak
Recruiting
Royal Oak
Minnesota
Children's Hospitals and Clinics of Minnesota - Minneapolis
Recruiting
Minneapolis
University of Minnesota/Masonic Cancer Center
Recruiting
Minneapolis
Mayo Clinic in Rochester
Recruiting
Rochester
Missouri
Columbia Regional
Recruiting
Columbia
Children's Mercy Hospitals and Clinics
Recruiting
Kansas City
Cardinal Glennon Children's Medical Center
Recruiting
Saint Louis
Mercy Hospital Saint Louis
Recruiting
Saint Louis
Washington University School of Medicine
Recruiting
Saint Louis
Mississippi
University of Mississippi Medical Center
Recruiting
Jackson
North Carolina
Mission Hospital
Recruiting
Asheville
UNC Lineberger Comprehensive Cancer Center
Recruiting
Chapel Hill
Carolinas Medical Center/Levine Cancer Institute
Suspended
Charlotte
Novant Health Presbyterian Medical Center
Recruiting
Charlotte
Duke University Medical Center
Recruiting
Durham
East Carolina University
Recruiting
Greenville
Wake Forest University Health Sciences
Recruiting
Winston-salem
North Dakota
Sanford Broadway Medical Center
Recruiting
Fargo
Nebraska
Children's Hospital and Medical Center of Omaha
Recruiting
Omaha
University of Nebraska Medical Center
Recruiting
Omaha
New Hampshire
Dartmouth Hitchcock Medical Center
Recruiting
Lebanon
New Jersey
Hackensack University Medical Center
Recruiting
Hackensack
Morristown Medical Center
Recruiting
Morristown
Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital
Recruiting
New Brunswick
Saint Peter's University Hospital
Recruiting
New Brunswick
Newark Beth Israel Medical Center
Suspended
Newark
Saint Joseph's Regional Medical Center
Recruiting
Paterson
New Mexico
University of New Mexico Cancer Center
Recruiting
Albuquerque
Nevada
Alliance for Childhood Diseases/Cure 4 the Kids Foundation
Recruiting
Las Vegas
Summerlin Hospital Medical Center
Recruiting
Las Vegas
Sunrise Hospital and Medical Center
Recruiting
Las Vegas
University Medical Center of Southern Nevada
Recruiting
Las Vegas
Renown Regional Medical Center
Recruiting
Reno
New York
Albany Medical Center
Recruiting
Albany
Montefiore Medical Center - Moses Campus
Recruiting
Bronx
Maimonides Medical Center
Recruiting
Brooklyn
Roswell Park Cancer Institute
Recruiting
Buffalo
NYU Winthrop Hospital
Recruiting
Mineola
The Steven and Alexandra Cohen Children's Medical Center of New York
Recruiting
New Hyde Park
Laura and Isaac Perlmutter Cancer Center at NYU Langone
Suspended
New York
Mount Sinai Hospital
Recruiting
New York
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
Recruiting
New York
University of Rochester
Recruiting
Rochester
State University of New York Upstate Medical University
Recruiting
Syracuse
New York Medical College
Recruiting
Valhalla
Ohio
Children's Hospital Medical Center of Akron
Recruiting
Akron
Cincinnati Children's Hospital Medical Center
Recruiting
Cincinnati
Cleveland Clinic Foundation
Recruiting
Cleveland
Rainbow Babies and Childrens Hospital
Recruiting
Cleveland
Nationwide Children's Hospital
Recruiting
Columbus
Dayton Children's Hospital
Recruiting
Dayton
ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital
Recruiting
Toledo
Oklahoma
University of Oklahoma Health Sciences Center
Recruiting
Oklahoma City
Oregon
Legacy Emanuel Children's Hospital
Recruiting
Portland
Oregon Health and Science University
Recruiting
Portland
Pennsylvania
Lehigh Valley Hospital-Cedar Crest
Recruiting
Allentown
Lehigh Valley Hospital - Muhlenberg
Suspended
Bethlehem
Geisinger Medical Center
Recruiting
Danville
Penn State Children's Hospital
Active, not recruiting
Hershey
Children's Hospital of Philadelphia
Recruiting
Philadelphia
Saint Christopher's Hospital for Children
Recruiting
Philadelphia
Children's Hospital of Pittsburgh of UPMC
Recruiting
Pittsburgh
Rhode Island
Rhode Island Hospital
Recruiting
Providence
South Carolina
Medical University of South Carolina
Recruiting
Charleston
Prisma Health Richland Hospital
Recruiting
Columbia
BI-LO Charities Children's Cancer Center
Recruiting
Greenville
South Dakota
Sanford USD Medical Center - Sioux Falls
Recruiting
Sioux Falls
Tennessee
T C Thompson Children's Hospital
Recruiting
Chattanooga
East Tennessee Childrens Hospital
Suspended
Knoxville
Saint Jude Children's Research Hospital
Recruiting
Memphis
The Children's Hospital at TriStar Centennial
Recruiting
Nashville
Vanderbilt University/Ingram Cancer Center
Recruiting
Nashville
Texas
Dell Children's Medical Center of Central Texas
Recruiting
Austin
Driscoll Children's Hospital
Recruiting
Corpus Christi
Medical City Dallas Hospital
Recruiting
Dallas
UT Southwestern/Simmons Cancer Center-Dallas
Recruiting
Dallas
El Paso Children's Hospital
Recruiting
El Paso
Cook Children's Medical Center
Recruiting
Fort Worth
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
Recruiting
Houston
Covenant Children's Hospital
Recruiting
Lubbock
UMC Cancer Center / UMC Health System
Recruiting
Lubbock
Children's Hospital of San Antonio
Recruiting
San Antonio
Methodist Children's Hospital of South Texas
Recruiting
San Antonio
University of Texas Health Science Center at San Antonio
Recruiting
San Antonio
Scott and White Memorial Hospital
Recruiting
Temple
Utah
Primary Children's Hospital
Suspended
Salt Lake City
Virginia
University of Virginia Cancer Center
Recruiting
Charlottesville
Inova Fairfax Hospital
Recruiting
Falls Church
Children's Hospital of The King's Daughters
Recruiting
Norfolk
Virginia Commonwealth University/Massey Cancer Center
Active, not recruiting
Richmond
Carilion Children's
Recruiting
Roanoke
Vermont
University of Vermont and State Agricultural College
Recruiting
Burlington
Washington
Seattle Children's Hospital
Recruiting
Seattle
Providence Sacred Heart Medical Center and Children's Hospital
Recruiting
Spokane
Madigan Army Medical Center
Recruiting
Tacoma
Mary Bridge Children's Hospital and Health Center
Recruiting
Tacoma
Wisconsin
University of Wisconsin Carbone Cancer Center
Recruiting
Madison
Marshfield Medical Center-Marshfield
Recruiting
Marshfield
Children's Hospital of Wisconsin
Recruiting
Milwaukee
West Virginia
West Virginia University Charleston Division
Recruiting
Charleston
Edwards Comprehensive Cancer Center
Recruiting
Huntington
West Virginia University Healthcare
Recruiting
Morgantown
Other Locations
Australia
John Hunter Children's Hospital
Recruiting
Hunter Regional Mail Centre
Women's and Children's Hospital-Adelaide
Recruiting
North Adelaide
Perth Children's Hospital
Recruiting
Perth
Princess Margaret Hospital for Children
Active, not recruiting
Perth
Sydney Children's Hospital
Recruiting
Randwick
Queensland Children's Hospital
Recruiting
South Brisbane
The Children's Hospital at Westmead
Recruiting
Westmead
Canada
Alberta Children's Hospital
Recruiting
Calgary
University of Alberta Hospital
Recruiting
Edmonton
IWK Health Centre
Recruiting
Halifax
McMaster Children's Hospital at Hamilton Health Sciences
Recruiting
Hamilton
Kingston Health Sciences Centre
Recruiting
Kingston
Children's Hospital
Suspended
London
Centre Hospitalier Universitaire Sainte-Justine
Recruiting
Montreal
The Montreal Children's Hospital of the MUHC
Recruiting
Montreal
Children's Hospital of Eastern Ontario
Recruiting
Ottawa
Centre Hospitalier Universitaire de Quebec
Recruiting
Quebec
Janeway Child Health Centre
Recruiting
Saint John's
Jim Pattison Children's Hospital
Recruiting
Saskatoon
Saskatoon Cancer Centre
Suspended
Saskatoon
Centre Hospitalier Universitaire de Sherbrooke-Fleurimont
Recruiting
Sherbrooke
Hospital for Sick Children
Recruiting
Toronto
British Columbia Children's Hospital
Recruiting
Vancouver
CancerCare Manitoba
Recruiting
Winnipeg
New Zealand
Christchurch Hospital
Recruiting
Christchurch
Starship Children's Hospital
Recruiting
Grafton
Puerto Rico
San Jorge Children's Hospital
Active, not recruiting
San Juan
University Pediatric Hospital
Recruiting
San Juan
Saudi Arabia
King Faisal Specialist Hospital and Research Centre
Suspended
Riyadh
Time Frame
Start Date: July 28, 2014
Estimated Completion Date: September 30, 2026
Participants
Target number of participants: 621
Treatments
Experimental: Group A (clinical observation)
Patients undergo clinical observation for 96 weeks in the absence of disease progression.
Experimental: Group B (clinical observation, first-line chemotherapy)
Patients undergo clinical observation for 3 years in the absence of disease progression. Upon disease progression, patients undergo surgery or receive first-line chemotherapy comprising carboplatin IV over 1 hour on day 1 (courses 1, 2, 4, 6, and 7), etoposide IV over 1 hour on days 1-3 (courses 1, 3, 4, 5, and 7), cyclophosphamide IV over 1 hour on day 1 (courses 2, 3, 5, 6, and 8), and doxorubicin hydrochloride IV over 15 minutes on day 1 (courses 2, 4, 6 and 8). Treatment with chemotherapy repeats every 21 days for 2-8 courses in the absence of disease progression or unacceptable toxicity. Once a PR or better is achieved, patients undergo clinical observation for 3 years.
Experimental: Group C (clinical observation, first-line chemotherapy)
Patients at high risk for deterioration and a poor outcome immediately receive first-line chemotherapy as in Group B. All other patients undergo clinical observation for 3 years in the absence of disease progression. Upon disease progression, patients receive first-line chemotherapy as in Group B. Once a PR or better is achieved, patients undergo clinical observation for 3 years.
Authors
Samuel O. Anim, Craig Erker, Lisa L. Hartman, Angela R. Girvin, John F. Kuttesch, Hamayun Imran, Mandy M. Atkinson, Joseph M. Wiley, Carola A. Arndt, Elyssa M. Rubin, Robin Y. Dulman, Haydar A. Frangoul, Frederick S. Huang, Neyssa M. Marina, Zhihong J. Wang, Ashley E. Meyer, Alberto S. Pappo, Nina S. Kadan-Lottick, Alissa Kahn, Corina E. Gonzalez, Sarah B. Whittle, Kathryn L. Laurie, Marcio H. Malogolowkin, Devang J. Pastakia, Jessica C. Hochberg, Anna B. Pawlowska, Douglas S. Hawkins, Mary L. Schmidt, Eduard H. Panosyan, Vinod K. Gidvani-Diaz, Julio C. Barredo, Afshan A. Ali, Vlad C. Radulescu, Matthew A. Kutny, Eric J. Lowe, Karol H. Kerr, Gary D. Crouch, Nadine P. SantaCruz, Mariko Sato, Caroline Y. Hu, Ashok B. Raj, Jessica M. Valdez, Jessica Boklan, Christopher N. Frantz, Keith J. August, Tanya C. Watt, Chana L. Glasser, Kishor M. Bhende, Lisa Gennarini, Stanton C. Goldman, Thomas W. McLean, Michael S. Isakoff, Kenneth G. Lucas, John J. Letterio, Justine M. Kahn, Kayelyn J. Wagner, Ziad A. Khatib, Mukund G. Dole, Michael J. Kelly, David L. Becton, Laura E. Agresta, Thomas W. Loew, Adit L. Tal, Lars M. Wagner, Phillip E. Barnette, Brian D. Weiss, Rabi Hanna, Birte Wistinghausen, Hardeo K. Panchoosingh, Timothy C. Griffin, Robin D. Hanson, Vonda L. Crouse, Vincent F. Giusti, Juan F. Rico, Erwood G. Edwards, Ranjan Bista, Doured Daghistani, Jennifer A. Domm, Don E. Eslin, William B. Slayton, Alyssa T. Reddy, Lolie C. Yu, Mark J. Mogul, Kamnesh R. Pradhan, Iftikhar Hanif, Aron Flagg, Holly E. Pariury, Holly J Meany, Mark A. Ranalli, David S. Dickens, Erin K. Barr, William C. Petersen, Leo Mascarenhas, Peri Kamalakar, Ray C. Pais, Jamie L. Dargart, Nibal A. Zaghloul, Sheri L. Spunt, Adonis N. Lorenzana, Jason Law, Duncan S. Stearns, Andrew L. Pendleton, Bethany G. Sleckman, Shelton A. Viola, Renuka Gera, Barbara A. Gruner, Yoko T. Udaka, Jose M. Esquilin, Manoo G. Bhakta, Susan L. Cohn, Rajen Mody, Erin M. Cockrell, Aarati V. Rao, Joseph C. Torkildson, Michelle A. Manalang, Clare J. Twist, Craig Lotterman, Erlyn C. Smith, Aniket Saha, Maria E. Echevarria, Colleen H. McDonough, Lisa M. Kopp, Hadi Sawaf, Eugenia Chang, Sandeep Batra, Aghiad Chamdin, Emily G. Greengard, Thomas B. Russell, Victor A. Lewis, Yi Zeng, Meghann P. McManus, Richard A. Drachtman, Luke D. Maese, Nicholas W. McGregor, Jennifer L. Reichek, James T. Badgett, Robert G. Irwin, Carla B. Golden, Elizabeth D. Alva, Meghan A. Higman, Roland L. Chu, Douglas J. Scothorn, Allen R. Chen, Eugene Suh, William T. Cash, Jonathan L. Metts, Aaron R. Weiss, Joanna G. Luty, Fouad M. Hajjar, Alison M. Friedmann, Carl Lenarsky, Judy L. Felgenhauer, Jacob A. Troutman, Pamela H. Kempert, Minnie Abromowitch, Michael J. McManus, Wade T. Kyono, Amy A. Smith, Robert J. Fallon, Kara-Marie H. Delaney, William D. Roberts, Mahmut Y. Celiker, Gregory P. Brandt, Gregory A. Hale, William S. Ferguson, Marshall A. Schorin, Scott M. Bradfield, Lisa M. McGregor, Robert M. Cooper, Nichole L. Bryant, Santosh S. Hanmod, Wendy L. Woods-Swafford, Susan G. Kreissman, Steven K. Bergstrom, Francis K. Eshun, Brian S. Greffe, Jeffrey R. Andolina, Sara Chaffee, Laura A. Campbell, Jennifer J. Welch, Jagadeesh Ramdas, Philip M. Monteleone, Stuart L. Cramer, Andrea R. Whitfield, Jeffrey A. Toretsky, Jay Michael S. Balagtas, Lauren M. Vasta, Joel A. Kaplan, Guy H. Grayson, Jean M. Tersak, Gregory E. Halligan, Bassem I. Razzouk, Brenda J. Wittman, Yung S. Yim, Katherine K. Matthay, Samuel J. Milanovich, Katharine Offer, India Y. Sisler, Madhu S. Gowda, Alan K. Ikeda, Samantha L. Mallory, Enrique A. Escalon, Yasmin C. Gosiengfiao, Dana A. Obzut, Nkechi I. Mba, Janice F. Olson, Laura K. Gowans, Rebecca E. McFall, Narayana Gowda, Michael K. Richards, Wayne L. Furman, Steven J. Kuerbitz, Meghen B. Browning, Koh B. Boayue, Alice Lee, Meredith S. Irwin, Lauren R. Weintraub, Mark E. Weinblatt, Jeffrey H. Schwartz, Jason M. Fixler, Sharon L. Gardner, Jill C. Beck, Suzanne Shusterman, Jennifer J. Clark, Julie Kim, Mary A. Bonilla, Peter D. Cole, Nanette H. Grana, Jessica A. Bell, Teena Bhatla, Jessica L. Heath, Albert Kheradpour, Jeffrey S. Dome, Melissa A. Forouhar, Edward F. Attiyeh, Maxine L. Hetherington, Mohamad H. Badawi, Pillai Pallavi Madhusoodhan, Steven L. Halpern, Bruce C. Bostrom, Stefanie R. Lowas, Farzana Pashankar, John J. Gregory, Jennifer H. Foster, Arun A. Rangaswami, Lydia A. Boateng, Susan J. Lindemulder, Emad K. Salman, Stuart H. Gold, Amy C. Fowler, Michael B. Harris, Luis A. Clavell, Douglas R. Strother, Kenneth B. De Santes, Felipe S. Bautista-Otanez, Christopher P. Keuker, Tanya R. Brown, Stephan R. Paul, Robin P. Corbett, Christopher Mpofu, Felicia L. Wilson, Violet Shen, Elizabeth L. Hesketh, Karen S. Fernandez, Batra Sandeep, Rebecca O. Clark, Jacqueline N. Casillas, Kathleen Felton, Ashley Chopek, Lisa A. Goodyear, Sharon B. Abish, Catherine H. Cole, Mark A. Winstanley, Laura Wheaton, Ayman A. El-Sheikh, Maria L. Kirby, Carol A. Portwine, Yvan Samson, Anne-Marie R. Langevin, Donna L. Johnston, David B. Dix, Pedro A. De Alarcon, Shannon M. Cohn, Tristan Pettit, Josee Brossard, Kenneth B. DeSantes, Uma H. Athale, Jacqueline M. Kraveka, Mary Meaghan P. Granger, Rochelle Bagatell, Jenna M. Demedis, Fataneh (Fae) Majlessipour, Nik Farahana N. Rashid, Nik F. Nik Abdul Rashid, Jennifer J. Greene Welch, Shayna M. Zelcer, Gail C. Megason, Rene Y. McNall-Knapp, Bhavna Padhye, Kathleen J. Yost, Jaime M. Libes, Marianne B. Phillips, Draga Barbaric, Helen Irving, Mohamad M. Al-Rahawan, Hector M. Rodriguez-Cortes, Mariana P. Silva, J. M. Johnston, Jenna M. Sopfe, Sarah J. McKillop, Ramamoorthy Nagasubramanian, Jonathan D. Fish, Sarah E. Leary, Geoff D. Cuvelier, Anderson (Andy) B. Collier, Bruno Michon, Conrad V. Fernandez, Kenneth Lieuw
Sponsors
Leads: Children's Oncology Group
Collaborators: National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov

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